vTv Therapeutics announces clinical hold placed on cadisegliatin program by FDA

vTv Therapeutics announced that the FDA has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment. The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion, or ADME, study of cadisegliatin that could not be resolved by standard mass spectroscopy. The Agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.